Two-Year Follow-Up Data Show Outstanding Clinical Outcomes and Safety for OrbusNeich’s Genous(TM) Stent in Patients at High Risk for Restenosis
HONG KONG, Aug. 16, 2011 /PRNewswire/ — OrbusNeich today announced that the that the company’s Genous Stent showed no significant difference in the rate of target vessel failure (TVF) at two years compared to the Taxus Liberte(TM) paclitaxel-eluting stent in patients with de novo coronary artery lesions carrying a high risk for restenosis. The two-year follow-up data from the prospective, randomized TRIAS pilot study were published in Catheterization and Cardiovascular Interventions.
No cases of stent thrombosis (ST) were observed in patients treated with the Genous Stent at two years, compared to five cases of ST observed in four patients treated with Taxus. The cumulative rate of cardiac death or myocardial infarction (MI) was 4.1 percent in the Genous group compared to 6.3 percent in the Taxus group.
“It is noteworthy that we did not see any stent thrombosis in patients with complex lesions treated with the Genous Stent,” said Marcel Beijk, M.D., of the Academic Medical Center, Amsterdam, and lead author of the paper. “We also saw that the Genous Stent tended to have fewer episodes of target lesion revascularization between one and two years.”
The single-center study investigated 193 patients of which 98 received a Genous Stent and 95 received a Taxus stent. Dual antiplatelet therapy was prescribed for at least one month after Genous Stent implantation and for at least six months after Taxus stent implantation.
“For patients with a high risk of restenosis who cannot tolerate the long-term dual antiplatelet therapy normally associated with DES, it is clear that the Genous Stent is an excellent alternative,” added Prof. Robbert de Winter, M.D., Ph.D., also of the Academic Medical Center, Amsterdam, and an author of the paper.
The study’s primary endpoint was TVF and secondary endpoints included non-cardiac death, target lesion revascularization (TLR), non-TVR and ST at two-year follow-up. TVF was defined as the composite of cardiac death, myocardial infarction and target vessel revascularization (TVR). High risk of restenosis was defined if one of the following applied: a chronic total occlusion, a stenosis with a length of greater than or equal to 23 mm, a lesion in a coronary artery with a diameter less than or equal to 2.8 mm by visual estimation or any lesion in a diabetic patient.
Genous is OrbusNeich’s patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
The Genous Stent, which has been commercially available in more than 60 countries since 2005, has been proven as a safe, effective alternative to drug eluting stents and is supported by data from more than 6,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world’s first pro-healing stent, the Genous Stent, as well as other stents and balloons marketed under the names of Azule(TM), R stent, Scoreflex(TM), Sapphire(TM), Sapphire II and Sapphire NC. Development stage products include the Combo(TM) Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.